The prevalence of off-label use and supratherapeutic blood levels of outpatient psychotropic medication in suicidal adolescents.

Introduction: Adolescents with mental disorders show an increased risk of suicidal phenomena. Vice versa, suicidality is a serious adverse event of psychotropic drug therapy in adolescents. There are only a few new psychotropic agents approved for this young age group. We evaluated the (pre-pandemic) prevalence of off-label use as well as detailed blood concentrations of outpatient psychotropic medication and sex differences in a clinical population of suicidal adolescents. Methods: The urine presence and serum levels of psychotropic substances of adolescents hospitalized due to their acute suicidality but without a known actual suicide attempt (i.e., no acute intoxication or serious self-injuries) were investigated routinely between 01.03.2017 and 31.01.2018. Urine (N = 205) and blood samples (N = 193) were taken at the beginning of closed inpatient admission, i.e., the results of the laboratory analysis reflect outpatient drug intake. The serum levels of psychopharmacological medication and OTC medication were measured. Results: Our sample consists of 231 cases (boys: N = 54; girls: N = 177, ratio: 1:3.3), aged 12-17 years (average age: 15,4 years). The most prevalent psychiatric diagnoses were depressive episodes (54%) and adjustment disorders (25%), and girls were more often diagnosed with depressive disorders than boys (boy/girl ratio: 1:9.5, p < 0.0001). More than half of adolescents (56%) used at least one prescribed psychotropic drug at admission (24.8% ≥ two psychotropic drugs). Off-label use of second-generation antipsychotics was significantly more frequent than off-label use of antidepressants (85% vs. 31%, p < 0.01). Adolescents suffering from depressive disorders were significantly more often on-label treated than adolescents with neurotic or stress-related disorders (56% vs. 10%). Female cases with prescribed psychotropic drug use showed significantly more frequent supratherapeutic drug levels than male cases (5% vs. 27%, p < 0.05). Conclusion: Female adolescents may have an increased risk of supratherapeutic blood levels, especially when outpatient prescribed psychotropic drugs are off-label used. Measurement of blood levels of outpatient-prescribed psychotropic drugs could be used to enhance the safety and efficacy of the individual psychopharmacological treatment of adolescent suicidal patients. There is an urgent need for more real-world evidence on the effective treatment of adolescents with psychotropic drugs.

[Non-Interventional Studies in a Large Community Hospital and Implementation of the General Data Protection Regulation (GDPR)]. / Nicht-Interventionelle Studien am Kommunalen Großkrankenhaus und die Umsetzung der Datenschutzgrundverordnung (DSGVO).

BACKGROUND: The General Data Protection Regulation (GDPR) is applicable as of May 25, 2018 in all member states to harmonize data privacy laws across Europe. GDPR impacts also on medical data research. Non-interventional studies (NIS) in hospital are an important part of health services research and might need to be assessed by the local data protection officer. This study investigates all NIS (in house or sponsored) initiated between April 1, 2017 and July 31, 2018 in Nuremberg Hospital and their methods dealing with the GDPR. MATERIALS AND METHODS: All studies in Nuremberg Hospital have to be reported to the study center of Nuremberg Hospital. We implemented some actions to fullfill GDPR, e. g. checklist for GDPR, quality circle, and all studies were assigned to a data protection officer specialized in scientific and clinical studies. We analyzed in each study the kind of data encryption (e. g., pseudonymous vs. anonymous), the need for approval from the official ethics commitee according to §15BO, and the need for approval from the hospital data protection officer. The data was analyzed using descriptive statistics. RESULTS: After GDPR came into effect, more NIS were started (n=77 vs. n=59), especially investigator-initiated NIS increased significantly (+84%, p<0.01). The majority of inhouse studies were dealing with absolute anonymous data (before GDPR: n=28 anonymous vs. n=4 pseudonymous; after R: 51 vs.7; n.s.). 22 studies, mostly IITs (86%), needed a statement of the local data protection officer and used a patient's information. After GDPR 19% of in-house NIS showed the need for a statement of approval from the ethics committee (accordingly to §15BO) (before GDPR 12.5%; n.s.). One year after GDPR was implemented, the average processing time of the data protection officer for an NIS was 10.5 work days. CONCLUSION: Investigator-initiated NIS are an important part of scientific research at Nuremberg Hospital. After GDPR, there was an increase in the number of self-initiated studies. Standardized procedures and simple actions help implement GDPR in medical research without critical delays at the start of study.

Attitudes and preferences concerning interprofessional education of first-year students and experienced medical and nursing staff.

In order to enhance patient outcome and patient safety in healthcare, interprofessional education (IPE) has over the years become a specific area of interest focusing on teaching concepts, research methods, and implementation strategies. To achieve commitment and positive attitudes as part of the institutional readiness towards IPE, the adoption of change management aspects can support its early implementation. This short report presents results of a baseline survey on attitudes and preferences for IPE among first-year students in medicine and nursing, as well as among chief physicians, nurse directors, and administrative directors at the associated university hospital. For the survey, the UWE-IP (University of the West of England Interprofessional Questionnaire) was used along with ten customised questions. Overall, a high degree of approval for IPE was observed in all participants. Furthermore, participants showed positive attitudes in three of the four UWE-IP subscales. However, neutral to negative attitudes were documented in subscale interprofessional interaction.

Health beliefs and over-the-counter product use.

BACKGROUND: Pharmacists are often consulted as medical advisors. Given this case, customers and pharmacists should interact in a trustful way (eg, in terms of responding to customer's needs or recommending a different drug). Consideration of the health beliefs of the customer could improve the interaction between pharmacists and their clients and have a positive impact on medical adherence. OBJECTIVE: To examine the health beliefs of pharmacy customers in Germany, the impact of those beliefs on over-the-counter (OTC) medication use, and associations with sociodemographic variables. METHODS: By means of literature review and methodical surveys, a standardized questionnaire was designed that contained 68 items concerning health beliefs, habits of OTC product use, decision criteria that customers used when purchasing drugs, and information about the sociodemographic background of the participants. Main outcome measures were reliability (Cronbach's alpha) and correlations. A random sample of 58 pharmacies in Saxony, Germany (10 questionnaires per pharmacy), invited their customers to take part in our study. RESULTS: One hundred twenty-three questionnaires (response rate 53.48%) were completed and returned to us. The outcome suggests that there is a strong association between health beliefs and frequency of use or the type of OTC drug (eg, illness attributions: p < 0.05; preventive lifestyle: p < 0.05). There were no significant associations between sociodemographic variables and chosen drugs. CONCLUSIONS: Health beliefs, in terms of the general attitude toward health and illness, illness attribution, prevention, and the attitude toward treatment strategies, influence the kind of remedy (conventional vs complementary medication) that consumers seek. These results may have implications for consultations in pharmacies or for product marketing.

Obesity and the risk for mental disorders in a representative German adult sample.

BACKGROUND: A systematic approach to examining associations among obesity and socio-demographic determinants, psychological problems, and mental disorders in epidemiological samples is missing. METHODS: Within the representative German Health Interview and Examination Survey and its Mental Health Supplement (GHS-MHS), 4181 subjects (age 18-65 years) took part in a physical examination (including measurement of body weight and height) and a standardized psychological interview (M-CIDI). Obesity (BMI > 30 kg/m(2)), somatic diseases, socio-economic variables, health-related quality of life (SF-36), and mental disorders (DSM-IV) were assessed. Data were analysed by logistic regression analyses. RESULTS: Prevalence of obesity was 18.5%. There was a strong association between obesity and somatic conditions, as well as to low socio-economic status (SES). No psychosocial disadvantages (e.g. regarding social relationships, impairment due to mental health problems, depressed feelings) for the obese individuals were found. With the exception of a higher prevalence of anxiety disorders in obese men (12.5 versus 8.5%, OR = 1.53, CI = 1.06-2.21, disappearing when controlled for number of somatic conditions), obese persons showed no elevated rates of mental disorders. DISCUSSION: Obesity is associated with a low SES and some somatic disadvantages but not with other social or emotional disadvantages that have been often assumed to be very prevalent in that group. From the population-based perspective, obesity per se seems not to be associated with a higher risk for suffering from mental disorders, whereas relations between specific aspects of obesity and specific types of psychopathology still need further study.

Associations between waist circumference and depressive disorders.

BACKGROUND: Previous research has suggested that abdominal obesity and mental disorders are associated. This paper was initiated to investigate associations between unfavourable waist circumference (WC) and mental disorders in a representative sample of German adults. METHODS: 4181 individuals (aged 18-65 years) took part in a physical examination (including measurement of body weight and WC) and a structured psychological interview (M-CIDI) to evaluate mental disorders. RESULTS: An unfavourable WC (males: 26.9%; females: 31.3%) was highly prevalent. However, unfavourable WC and mental disorders were not associated, neither with regard to the prevalence of any mental disorder nor regarding in particular depressive disorders. Moreover, even middle-aged depressive women that have often been assumed to be at high risk of increased visceral fat did not show more unfavourable WCs than their non-depressed, female counterparts. LIMITATIONS: The main limitation is that the co-occurrence of mental disorders and obesity was recorded but not, if obesity was related to the onset of mental problems. CONCLUSION: From an epidemiologic perspective, it is not possible to prove associations between WC and mental disorders. Patients with unfavourable waist circumferences do not show a higher prevalence of depressive disorders.

[Drug information centers-instruments for health care research?]. / Arzneimittelberatungsdienste als Instrumente der Versorgungsforschung.

BACKGROUND: Patient- and physician-centered drug information services (DICs) can contribute to a better communication between doctors and patients and health care research. Furthermore, gaps within health care can be identified. METHODS: Data of two DICs (the physician-centered service is in operation for almost 10 years, the patient-centered service since 2001), both established in the Institute of Clinical Pharmacology of the TU Dresden, Germany, were analyzed using descriptive statistics. RESULTS: The consultation frequency in both DICs was high (2004: 129 enquiries by physicians; 1,358 by patients). Questions concerning highly prevalent drug groups, i. e., cardiovascular drugs (physicians: 20%; patients: 30%) and drugs targeting the central nervous system (physicians: 22%; patients: 17%) were asked most frequently. CONCLUSION: The results indicate that patient's drug information in primary care needs improvement. Although in both DICs similar drug groups were asked, the authors suggest that the time factor is the core obstacle to sufficient information rather than knowledge deficits of physicians.

Drug use patterns in young German women and association with mental disorders.

BACKGROUND: There is a lack of data about drug use patterns in young women. Mental disorders may influence those drug use patterns. OBJECTIVE: To evaluate drug use patterns (prescribed drugs, self-medication) in general and in relation to the prevalence rates of mental disorders in young German women. METHODS: A total of 2064 women (18-24 y old), obtained in a random clustered sample, were asked about their actual and former medication use. Moreover, a structured psychological interview (Diagnostic Interview for Mental Disorders) was conducted with each woman to evaluate the prevalence of mental disorders (according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition). RESULTS: Oral contraceptives (55.9%), thyroid preparations (7.1%), respiratory system drugs (9.4%), and nervous system drugs (8%) were the most commonly used medications. Only 10% of the women with one or more mental disorders used psychotropic medication. As expected, women with mental disorders were significantly more likely to use antidepressants and psycholeptic agents (ie, sedatives/hypnotics, antipsychotics) than were women without any mental disorder. However, there were no significant differences in use of pain medication. CONCLUSIONS: The results of this study indicate an apparently inadequate supply of drugs acting on the nervous system for women with mental disorders in Germany. Further studies on different age and gender groups are needed. It is important to evaluate the prevalence of diseases and drug use at the same time so as to identify deficits in drug therapy and optimize prescription and self-medication use.